CHMP rebuffs Novartis' serelaxin for AHF

EMA's CHMP recommended against approval of Reasanz serelaxin ( RLX030) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat acute heart failure (AHF). The committee said the safety of serelaxin "seemed acceptable" but that the compound's benefits do not outweigh its risks because of uncertainties about serelaxin's benefits. CHMP noted that serelaxin did not show short-term relief of dyspnea and that while serelaxin did relieve dyspnea over five days, the clinical relevance for AHF was not clear. CHMP also noted that Novartis' analyses did not include data from patients who had died or required additional treatment and questioned whether differences in background therapy influenced the data. ...